Late last year, House appropriators killed a direct-to-consumer advertising user fee authorized by the FDA Amendments Act (FDAAA) largely because they felt that FDA does not regulate drug advertising forcefully enough. And they nixed funding for the new Reagan-Udall Foundation because of fears that it will permit biopharmaceutical executives to exert more influence on agency research programs.
At the annual meeting of the Food and Drug Law Institute (FDLI) in March, Carl Peck, former director of the Center for Drug Evaluation and Research (CDER), described FDA as operating in a "guerrilla environment" created by "ambitious politicians, media competing for headlines, and opportunistic academics." A case in point, he noted, was a widely cited study in the New England Journal of Medicine indicating that new drugs approved close to user fee deadlines turn out to be less safe than those approved without any pressure to meet review timeframes. But FDA said that it's not true. CDER Deputy Director Douglas Throckmorton responded that agency approval and withdrawal data are "considerably different" from what the analysts reported. FDA plans to submit its findings to the New England Journal of Medicine, but even a strong refutation is unlikely to make front-page news.STRETCHED THIN
FDA is having difficulty meeting the high expectations of all its constituencies because of an ever-expanding portfolio of oversight and regulatory responsibilities, coupled with depleted resources and a decimated work force. The need to establish a host of new rules and policies to implement FDAAA makes matters worse, at least for the short run.
The situation has become so serious that John Jenkins, director of CDER's Office of New Drugs, is giving review division chiefs leeway to "reduce work as needed on a case-by-case basis," even if that means missing user fee review deadlines. Jenkins explained to reporters that his office cannot keep up with growing requests to meet with sponsors, to provide special protocol assessments for innovative therapies, to fulfill information demands from Congress, and still meet stated user fee timelines. Jenkins noted that there is "no specific end date" to the possibility of missing Prescription Drug User Fee Act (PDUFA) deadlines because it may take years to hire all the necessary personnel to remedy the situation.
For manufacturers, this raises the prospect of added delays and higher costs in bringing new treatments to market. FDA approved only 19 innovative new drugs in 2007: 17 new molecular entities plus two novel biotech therapies. That's way down from the peak of 53 new drugs in 1996, but in line with a steady decline in new drug approvals since 2002. Manufacturers believe this trend reflects a "new environment" at the agency, noting that FDA reviewers are issuing more nonapprovable and approvable letters and routinely request additional studies. FDA officials counter that they have not changed standards, but have become better at detecting and defining safety problems.